Dual insufflation and wound closure devices and methods

ABSTRACT

A dual functioning instrument set, comprising a needle and guide, has not only the capabilities to enter and insufflate the abdominal cavity but also the ability of a suture passer to carry and retrieve suture for closure of the incision sites at the end of the procedure. The needle contains a deployable snare that is used to pass and retrieve suture. The guide is used to repeatedly locate the needle relative to the inner abdominal wall allowing for consistent placement of sutures. For insufflation purposes, obturator tips having different distal structures are provided for shielding the sharp needle tip after insertion through a body wall.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Non-Provisional patentapplication Ser. No. 14/825,452, filed Aug. 13, 2015, the disclosure ofwhich is incorporated by reference herein.

BACKGROUND OF THE INVENTION 1. Field of the Invention

This invention relates to surgical instruments for approximation,ligation and fixation of tissue using a suture, and particularly to theapproximation of tissue separated by means of an endosurgical trocarbeing inserted into a body cavity. This invention also relates to theaccess to an anatomic cavity or space during a medical procedure, andparticularly to insufflations of the abdominal cavity for laparoscopicsurgery.

2. Description of Prior Art and Related Information

Numerous methods currently exist for performing laparoscopic procedures.One of the more commonly used methods is known as closed laparoscopywhich utilizes a sharp needle (eg. Veress needle) to puncture theabdominal wall and insufflate the abdominal cavity with an inert gassuch as carbon dioxide through the needle. This process of insufflatingthe cavity separates the abdominal wall from the underlying organscreating a gap for the surgeon to work within. A trocar/cannula systemis then used to maintain the insufflated cavity and provide a workingportal for which instruments can be passed into and out of the abdominalcavity to perform various surgical procedures. When the procedure iscompleted, it is desirable for the surgeon to close the incision siteusing suture material to minimize the risk of adverse post-operativeevents.

Insertion of the needle into the abdomen is performed without any visualaid to facilitate location of the sharp needlepoint. In order to reducethe probability of inadvertent penetration of delicate internal organsin this “blind” procedure, the sharp insufflation needle contains arounded member disposed within the lumen of the needle, and biased by aspring to an extended position beyond the needle tip.

The conventional insufflation needle also includes a means forintroducing an inert gas into the abdominal cavity through a channel oropening within the lumen of the needle. A luer or other quick connecttype adapter is typically housed within the proximal handle of theneedle to connect a gas source to the needle. The gas then travels fromthe handle through the length of the needle and exits into the bodycavity from the distal tip of the needle.

One of the post-operative complications associated with this procedureis the incidence of trocar site hernias, where a portion of an organ orfatty tissue protrudes out through the hole in the abdominal wallcreated by the trocar access portal. It is believed that improperclosure, or complete lack of closure, of the incision site at theperitoneum is the primary cause of these hernias which form during thepost-operative period ranging from several days to several monthsfollowing the procedure. Traditional methods of wound site close requirean additional set of instruments (suture passers, guides, etc.) to beintroduced into the surgery. A number of these instruments have beenpreviously disclosed. However, the prior art related to trocar woundsite closure instrumentation are typically cumbersome to use and do notprovide for a simple, reproducible, and reliable means of closing thewound site.

In order to safely perform a closed laparoscopic procedure, both aVeress needle and a suture passing device may be purchased and used forthe completion of the procedure. This can be both expensive and createadditional waste, unnecessarily. The present invention comprises acombination device that can provides the multiple functions that werenot previously offered in the prior art.

BRIEF SUMMARY OF THE INVENTION

In accordance with the present invention, structures and associatedmethods are disclosed which address these needs and overcome thedeficiencies of the prior art. A preferred system according to theinvention comprises a surgical instrument as well as a surgicalinstrument set that may have one or two basic functions.

First, the system may have the capabilities to provide entry into theabdominal cavity and subsequently insufflating the cavity for use inlaparoscopic surgical procedures. In the preferred embodiment, thesystem comprises a needle apparatus having a sharp needle tip and aninsufflation channel to facilitate penetration into the abdominal cavityand insufflation. A unique obturator tip is provided to shield the sharpneedle tip upon insertion into the cavity.

Second, the system may have the capabilities to close thefascial/peritoneal layer at the trocar wound site in a quick, consistentand reproducible manner at the end of the procedure. To facilitateclosure of the wound, the system includes a guide used in combinationwith the same needle apparatus which also serves as a suture engagingdevice. In the preferred embodiment, the system would have both of thecapabilities described above.

The needle apparatus may be able to function like a suture passer, inthat it has the ability to carry and retrieve suture through tissuelayers for suturing closed the wound site. The needle also has theability to insufflate the abdomen during the laparoscopic procedure. Theneedle apparatus may comprise several components including: a handle,actuation mechanisms, means for connecting the needle to a gas line, adeployable snare, a needle tip, a hollow inner shaft inside the needletip, and a safety mechanism plunger disposed within the needle tip.

In a preferred embodiment, a handle at the proximal end of the needleapparatus allows for single-handed or double-handed use. An actuatormechanism is disposed adjacent to the handle and configured for thedeployment and retraction of the snare used to pass and retrieve thesuture material. The preferred actuator mechanism may include a firstactuator comprising sliding trigger that translates along the long axisof the handle that locks the snare against the needle when it is in oneposition, and partially deploys the snare loop when the trigger is setinto a second position. This trigger may be spring loaded to ease thedeployment of the snare from within the needle. A second actuator maycomprise a sliding plunger, or extender rod, that exits from theproximal end of the handle and translates along the long axis of thehandle. This extender rod would be used to fully deploy the snare. Thehandle and actuator means may be constructed from metals (such asstainless steel, titanium, or aluminum) or plastics (such as polyacetal,nylon, PEEK, or polycarbontae), or any combination of the two.

The snare accomplishes the suture passing capabilities of the needleapparatus. As previously stated, the snare may be actuated between threedifferent positions: (1) completely retracted into the needle shaft, (2)partially deployed, and (3) fully deployed. When the snare is completelyretracted into the needle shaft, the suture material would be capturedbetween the snare and the inner shaft of the needle apparatus. When thesnare is partially deployed, a small loop section of the snare would beexposed. This partial deployment of the snare may allow for certainsimple suture passing steps to be accomplished without having to fullydeploy the snare. When the snare is fully deployed, a larger loopsection of the snare would be exposed that is significantly greater insize than the partially deployed loop. The fully deployed snare would bemost useful when trying to retrieve the free end of the suture withinthe body cavity by providing a large target in which the suture can begrasped. Optimally, the snare would be deployed perpendicular to thelong axis of the needle to simplify the suture passing process, howeverthe snare may be deployed over a broader range of angles from the needleranging from 0-180 degrees relative to the long axis of the needle. Thesnare would most optimally be manufactured from a shape memory alloymaterial such as Nitinol, but may also be made from other metallic orpolymeric wire materials.

A long outer needle shaft may be connected to the proximal handle andextends distally over a length that may range from 1-15 inches. Theouter needle shaft may have a sharp tip, or needle peak, at thedistal-most point to ease the insertion of the needle through thevarious tissue layers. The outer shaft may house an inner shaft that hasa hollow, unobstructed inner lumen. This unobstructed inner lumen mayallow for the passage of an inert gas for insufflation of the abdomen. Aluer connector or other quick connect type device may be disposed on theproximal handle to provide an entry passageway for the gas to enter intothe needle. The unobstructed inner lumen may also provide a passagewayfor the snare material to travel up through the needle portion and intothe handle so that it can be connected to the actuator mechanism.

The distal-most end of the inner shaft may have a blunt obturatorattached to the tip. The entire inner shaft may be spring loaded toallow for the blunt obturator to translate away from the tip of theneedle when it is loaded, and passively travel back to the tip of theneedle when it is unloaded. The obturator spring may be housed withinthe handle. The spring loaded obturator would serve as a safetymechanism for protecting the internal organs within the abdomen. Theinner and outer needle shafts would optimally be constructed frommetallic tubes such as stainless steel. The obturator tip may bemanufactured from a number of different materials including, but notlimited to, metals and plastics.

In another preferred embodiment, the needle apparatus may have a singleactuator to control the snare between a fully exposed position and afully retracted position. The single actuator may comprise a lockouttrigger similar to the first preferred embodiment, except that thelockout trigger can proximally translate with respect to the housing agreater distance so as to proximally push the slide rod connected tosnare all the way to fully expose the snare.

The guide apparatus may be used to guide the needle through theabdominal wall in a repeatable manner. The guide may comprise an outerhousing, or barrel, and an inner plunger used to actuate the guide.

The barrel may have two or more counterforce tabs, or extension tabs, atthe proximal end to aid in the handling and insertion of the guide intothe abdomen. These counterforce tabs may provide surfaces for the userto utilize two fingers to hold the barrel. For example, the index fingerwould be placed under one tab, and the middle finger is placed under thesecond tab. The thumb may then be used to actuate the proximal surfaceof the plunger and secure the guide within the user's grasp.

The distal end of the barrel would have a blunt tip to minimize thepotential of harm or damage to the adjacent tissue during insertion.Just proximal to the blunt tip the barrel may have a deformable securingmechanism that may have two configurations. The first configuration ofthe deformable section would be aligned with the wall of the outerhousing such that the structure has a slender, continuous outerdiameter. This first slender position would be utilized during theinsertion of the guide into the cavity. The deformable section can thenbe deformed to a second flared out position where securing mechanismextends beyond the outer diameter of the outer housing. The securingmechanism, comprising expanding feet in the preferred embodiment, isused to place the guide against the inner wall of the abdomen to providea reference point for the needle to be repeatedly placed in the samelocation of the abdominal wall that is required to be sutured forclosure of the portal site.

Along the central portion of the shaft of the barrel are multiple slotsin the shaft wall. These slots serve to provide a passageway for theneedle apparatus to travel to the appropriate location of the abdominalwall for the placement of sutures. Two slots may be placed opposing eachother near the proximal end of the shaft, and two additional slots maybe placed opposing each other near the distal end of the shaft. Theproximal slots may serve as the entry points for the needle, while thedistal slots may serve as the exit points for the needle. The guide alsoincludes axial wings, which may be extruded, extending away from thecentral axis of the shaft to aid in pushing away fatty tissue that isundesirable tissue for the suture to pass through. Particularly if thesefeatures are located near the distal slots where the needle is exitingthe guide, the risk of suturing unwanted fatty tissue is minimized.

The guide may comprise a plunger slidably disposed within the barrel.The plunger may be used to actuate the expanding feet, comprising livinghinges in the preferred embodiment, on the barrel. This plunger may bespring loaded such that the plunger is biased to the radially expandedposition. When the plunger is in the biased flared out position, thefeet would be in the expanded position. When the plunger is pressed tothe first position, the feet would be retracted back to a position thataligns the outer diameter of the outer housing in a continuous slenderfashion. The plunger may be attached to the distal end of the barrel.Along the shaft of the plunger would be through holes that align withthe outer housing slots to accommodate passage of the needle apparatusthrough the guide. These through holes may intersect each other or maybe offset such that the holes do not intersect one another. All of theguide components would preferably be made from an injection moldablepolymer (such as polycarbonate, polyacetal, nylon, or ABS) but the guidemay be machined from other plastics and/or metals.

The basic procedural steps for abdominal entry and insufflation of thecavity may flow as follows. The needle is used to enter the abdominalcavity using standard closed laparoscopic techniques. A gas line isconnected to the handle allow for an inert gas to be passed into theabdominal cavity. The inert gas is then turned on until the cavityreaches an appropriate level of insufflation to allow for the procedureto be performed with appropriate visualization. The needle is thenremoved, and a trocar is inserted into the puncture site to perform theprocedure.

The basic procedural steps of the utilization of the suturing system mayflow as follows. At the end of the surgical procedure, the trocar isremoved and the needle guide is placed into the wound. The expandablefeet are deployed against the inner wall of the peritoneum. A short endof a suture tail is captured within the snare, while outside the bodycavity. Then the needle apparatus is advanced through the needle guideand tissue layers into the abdominal cavity, carrying the suture withit. The snare is expanded to release the suture. The needle apparatus isthen removed from the guide and reinserted through the opposite side ofthe guide on the opposite side of the puncture wound. When the distalend of the assembly is exposed in the abdominal cavity, the snare isexpanded to provide an easy target to secure the existing suture tailinside the abdominal cavity. Once the suture has been secured within thewire snare, the needle apparatus is removed to outside the body cavity,bringing the suture along with it. The suture is then released from thesnare wire. The suture is in place to be tied with a knot to provideclosure the trocar puncture site. This suturing procedure may also beaccomplished without the use of the needle guide.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1B show a preferred embodiment of a needle guide in an actuatedposition with a securing mechanism not expanded;

FIGS. 1C-1D show the preferred needle guide in the resting position withthe securing mechanism expanded;

FIG. 2 is a cross sectional view of the preferred needle guide showingthe needle tracks;

FIG. 3 shows the guide as it is placed through a section of tissue withthe expanded feet resting against the inner peritoneal wall;

FIG. 4A shows an oblique view of the needle with the snare fullyretracted into the needle;

FIG. 4B shows an oblique view of the needle with the snare partiallyextended;

FIG. 4C shows an oblique view of the needle with the snare fullyextended;

FIG. 5A is a cross-sectional view of the needle housing showing theinternal components of the needle corresponding to the fully retractedsnare position in FIG. 4A;

FIG. 5B is a cross-sectional view of the needle corresponding to thepartially extended snare position shown in FIG. 4B;

FIG. 5C is a cross-sectional view of the needle corresponding to thefully extended snare position shown in FIG. 4C;

FIG. 6A is a detail view of the distal tip of the needle with the springloaded safety obturator;

FIG. 6B is a cross-sectional view of the distal tip of the needle;

FIG. 6C is a close-up perspective of the housing of the needle apparatusshowing a preferred lockout trigger;

FIG. 7A is an oblique view of a standard retractable obturator tipdesign;

FIG. 7B demonstrates the relative distance from the tip of the needle tothe tip of the obturator;

FIG. 7C is an oblique view of an alternative retractable obturator tipdesign;

FIG. 7D demonstrates the relative distance from the tip of the needle tothe tip of the alternative obturator;

FIGS. 8A-C show various alternative embodiments of the handle portion ofthe needle;

FIG. 9 shows the suture being loaded into the snare;

FIG. 10 shows the needle passing suture through the guide and tissue;

FIG. 11 shows the needle being used to retrieve the free end of thesuture;

FIG. 12 illustrates a preferred method for insufflating a body cavityand engaging a suture to close a wound using a single device; and

FIG. 13 illustrates a preferred method for closing a surgical woundusing a system comprising preferred embodiments of a guide and a sutureengaging device disclosed above.

FIG. 14 is a perspective view of a second preferred embodiment of aneedle apparatus comprising a single actuator mechanism with the snarein the fully exposed position;

FIG. 15 is a perspective view of the second preferred needle apparatusshowing the snare in the fully retracted position.

The various embodiments of the invention can now be better understood byturning to the following detailed description wherein illustratedembodiments are described. It is to be expressly understood that theillustrated embodiments are set forth as examples and not by way oflimitations on the invention as ultimately defined in the claims.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS AND BEST MODE OFINVENTION

In a preferred embodiment, a system 100 is provided for insufflating anabdominal cavity and closing a trocar wound site. The system 100comprises a guide and a single device having dual functionalities ofinsufflation and suture engagement.

FIGS. 1A-1D illustrate a preferred embodiment of a surgical guideapparatus, or simply guide, 10 for directing surgical instrumentsthrough a body wall. The guide 10 may be particularly useful fordirecting suturing devices used in closing wounds, or openings throughbody walls, made in surgical procedures to access internal bodycavities. The guide 10 comprises a radially expandable securingmechanism 26 at a distal end 16 that is configured to secure the guide10 to the inner wall of a body cavity, such as the peritoneumsurrounding an abdominal cavity in the case of a laparoscopic procedure.

In FIG. 1A, a plunger 21 is slidably disposed within a barrel 23 havinga barrel proximal portion 15 and a barrel distal portion 17. The plunger21 and barrel 23 may be connected to each other by deformable lockingtabs 29 at a distal end 12 of the plunger 21, that lock within the bluntdistal end cap 30 of the barrel 23. At a proximal end 14 of the plunger21 is an actuation surface 22 that may be flat or contoured that allowsfor the plunger to be pressed down to slide the plunger 21 within thebarrel 23.

As the plunger 21 translates with respect to the barrel 23, the radiallyexpandable securing mechanism 26 at the distal end 16 of the barrel 23moves between two positions of radially expanded, or flared out, asshown in FIGS. 1C and 1D, and radially contracted, or slender, as seenin FIGS. 1A and 1B. In the preferred embodiment, the internal cavitysecuring mechanism 26 comprises two or more expanding feet 26 radiallyspaced apart from each other. The expanding feet 26 each preferablycomprise a living hinge section composed of the same material as thebarrel 23, where the material is cut thin at specific locations allowingfor the material to flex. It is to be expressly understood that theradially expandable securing mechanism 26 may comprise a variety ofstructures capable of moving between slender and flared-outconfigurations. Radially adjacent to the expanding feet 26 may be one ormore distally extending stop tabs 31 on the barrel, as shown in FIGS. 1Aand 1B. The stop tabs 31 are configured to provide a mechanical stop forthe distal end cap 30 of the barrel 23 to collide against to prevent theplunger 21 from over-translating and potentially damaging the thinsection of material within the expanding feet 26.

In FIGS. 1B and 1D, two counterforce tabs, or extension tabs, 24 arepreferably disposed near a proximal end 18 of the barrel 23 andconfigured to be grasped with one or more fingers while the thumb may beused to press down on the actuation surface 22. The counterforce tabs 24facilitate ease of handling of the guide 10. The guide 10 comprises atleast one needle entry slot 27 in the barrel proximal portion 15preferably distal to the counterforce tabs 24.

In the preferred embodiment, the guide 10 provides two different,diagonal pathways for a needle apparatus and thus comprises first andsecond entry slots 27 a, 27 b as more clearly shown in FIG. 2. Thesebarrel entry slots 27 a, 27 b provide for entry points for a sutureengaging device, or needle apparatus, to enter the guide 10. The twobarrel entry slots 27 a, 27 b are preferably axial in that they 27 a, 27b extend over a length that is parallel to a long axis “A” of the guide10. The barrel entry slots 27 a, 27 b are preferably equally spacedapart in a radial manner from each other, i.e., 180 degrees apart ifthere are two slots, 120 degrees apart if there are three slots, etc.The guide 10 comprises barrel exit slots 28 a, 28 b equal in number tothe entry slots 27 a, 27 b and located distally along the barrel 23.

The guide 10 is useful for directing suture engaging devices, andparticularly a preferred embodiment of a suture engaging devicediscussed further below and identified simply as a needle apparatus.Accordingly, the guide 10 preferably comprises two pathways diagonal toeach other and oriented to direct a needle apparatus to both a firstinternal location to carry and release a suture, and a second internallocation preferably horizontally opposite to the first internal locationin order to facilitate retrieval of the suture using the preferredsuture engaging device discussed further below.

FIG. 2 is a cross sectional view of the guide 10 showing the preferreddual pathways that a surgical instrument, such as a needle apparatus orsuture engaging device, can take through the guide 10. The guide 10preferably comprises first and second plunger entry points 33 a, 33 badjacent to the plunger proximal end 14 and first and second plungerexit points 34 a, 34 b adjacent to the plunger distal end 16. A firsttunnel, or first track, 35 a defines a first track axis “μl” and is incommunication with both the first plunger entry 33 a formed on a firstside of the plunger 21 and the first plunger exit 34 a which ispreferably formed on an opposing side of the plunger 21. The first entry33 a, first tunnel 35 a and first exit 34 a collectively form a firstneedle pathway that is preferably oblique to the guide axis “A.”

A second tunnel, or second track, 35 b is in communication with both thesecond plunger entry 33 b formed on the second side of the plunger 21and the second plunger exit 34 n which is preferably formed on theopposing first side of the plunger 21. Thus, the first and secondtunnels 35 a, 35 b are preferably off-axis and diagonal to each other.These tunnels 35 a, 35 b may intersect each other as shown, or havetheir paths offset such that they do no intersect. The second entry 33b, second tunnel 35 b and second exit 34 b collectively form a secondneedle pathway oblique to the guide axis “A” and diagonal to the firstpathway. The plunger 21 on the guide 10 may be passively controlled by aspring 32 that is housed between the plunger 21 and barrel 23 to keepthe guide in the biased open position with the feet 26 expanded. It willbe appreciated that biasing the guide 10 to this hands-free operativeconfiguration with the feet 26 expanded and the pathways open frees upboth of the surgeon's hands to work with other instruments when theguide 10 is inserted into the trocar wound.

The barrel needle exit slots 28 may be surrounded by up to two opposingtissue distraction wings 25. These wings 25 help separate unwantedtissue away from the needle exit slots 28.

In the case of a laparoscopic surgery involving use of a trocar, theguide 10 may be placed through the tissue layers of the open trocarwound site as shown in FIG. 3 after the trocar has been removed. Thistissue may consist of the skin 36, adipose tissue 37, muscle and fascia38 and peritoneal layer 39. Prior to insertion of the guide 10, the feet26 are in the slender, non-expanded position with the plunger 21pressed. Once the distal end 12 of the guide 10 is appropriately placedunder the peritoneal layer, the plunger 21 is released and spring-biasedto the operative configuration causing the living hinges 26 to expand asshown in FIG. 3. With the radially expandable securing mechanism 26 inthe flared out configuration, the guide 10 can then be pulled up againstthe inner peritoneum to align the needle tunnels 35 a, 35 b with theappropriate tissue layers for suturing. The plunger entry holes 33 forthe needle apparatus are positioned above the outer skin layer 36, whilethe plunger exit holes 34 for the needle apparatus should be positionedjust above the muscle and fascia layer 38 to be sutured. The tissuedistraction wings 25 aid in pushing away unwanted adipose 37 or fattytissue from the needle exit holes 34 such that primarily muscle andfascia tissue 38 is sutured.

FIGS. 4A-4C illustrate a preferred embodiment of a dual insufflation andwound closure device, or simply needle apparatus, 49 which may be usedin connection with the preferred guide discussed above. The needleapparatus 49 serves the dual purposes of insufflating an abdominalcavity as well as engaging and passing suture to close a wound. Theneedle apparatus 49 includes a puncture closure mechanism, or sutureengaging mechanism, preferably comprising a deformable snare 57 movablebetween three functional positions as depicted in FIGS. 4A-4C. Thesuture snare 57 may be fully retracted within a needle shaft assembly,or simply needle shaft, 55 (FIG. 4A), partially extended (FIG. 4B) to atemporary fixed position, or fully extended (FIG. 4C). The snare 57 maycomprise a single wire or, preferably, a plurality of interwoven strandsto reduce strain and allow for a greater angle of flexure. The snare mayalso include in curvature in shape to reduce stain and prevent the snarefrom experiencing permanent deformation. In the preferred embodiment,the deformable snare 57 is composed of a shape memory alloy materialsuch as Nitinol, but may also be made from other metallic or polymericwire materials.

In the preferred embodiment, a rod assembly, or slide rod, 53 is coupledto the snare 57. The rod assembly 53 comprises a rod distal portion 53-1connected to the snare 57 and disposed within the shaft assembly 55 anda rod proximal portion 53-2 protruding out from the housing proximalportion 46. In the preferred embodiment, the rod distal portion 53-1 isintegral with the rod proximal portion 53-2, although the two rodportions 53-1, 53-2 may comprise separate pieces axially coupled to eachother.

In the preferred embodiment, a dual actuator mechanism 45 disposedadjacent to a proximal end of the needle housing 50 controls theposition and configuration of the snare 57. The dual actuator mechanism45 preferably comprises a first actuator 53 configured to move the snare57 between the fully exposed position and the fixed partially exposedposition, and a second actuator 52 configured to move the snare 57between the fixed partially exposed position and a fully retractedposition. The needle housing 50 comprises a housing proximal portion 46and a housing distal portion 47.

The first actuator 53 preferably comprises a slide rod, or extender rod,53, axially protruding out from the housing proximal portion 46. A knob54 may be coupled to the proximal end of the rod proximal portion 53-2to facilitate use of the first actuator 53. In the preferred embodiment,the slide rod 53 is slidably disposed within the needle housing 50, andcoupled to the snare 57 that travels through the needle housing 50 andneedle shaft 55 to the distal tip of the needle 56. When the slide rod53 is fully pushed into the needle housing 50 in a distal direction, thesnare 57 is fully extended (as in FIG. 4C).

Since the deformable snare 57 is composed of a material having shapememory characteristics, the snare 57 is preconfigured to form a loopthat is substantially perpendicular to the shaft axis A when fullyexposed. In this fully exposed configuration as shown close-up in FIG.11, the snare 57 forms an elongate loop having a distal loop tip 61connected to a pair of distal loop sections 62, which are preferablylinear, which are connected to arched majority loop sections 63. As thesnare 57 is moved from the partially exposed position to the fullyexposed position, the snare 57 forms a loop that not only increases insize, but also curves back towards the shaft 55 to form a perpendicularorientation with respect to the shaft axis “A.” Thus, the snare 57travels an arcuate path bent towards the shaft 55 as the snare 57 movesfrom the partially deployed to the fully deployed configuration.

When the slide rod 53 is proximally pulled toward an extended,protruding position as shown in FIG. 4B, the deformable loop decreasesin size as the snare 57 is retracted into the needle distal tip 56. Whenpulled in the proximal direction, the slide rod 53 will continue toretract the snare 57 until the distal loop tip 61 contacts the exit rampof the obturator. The first actuator 53 is partially spring loaded in amanner that only when the slide rod 53 nears the fully extended proximalposition, the slide rod 53 engages the first spring mechanism 64 whichbiases the slide rod 53 distally to a rest position. This spring-biasedrest position corresponds to the fixed partially exposed position of thesnare 57, shown in FIGS. 4B and 9. It will be appreciated that thepartially exposed position as shown in FIG. 4B is fixed in the sensethat further retraction of the snare 57 beyond this point requiresactuation of the second actuator, which in the preferred embodimentcomprises proximal movement of the thumb slide 52 as discussed furtherbelow.

This partial spring loading of the slide rod 53 allows for the snare 57to rest in the fixed partially exposed without actuation. In this fixedpartially exposed configuration, the snare 57 protrudes sideways fromthe needle shaft 55 and forms a substantially planar loop where the twolinear loop sections 62 are substantially parallel to each other asshown in FIG. 6A. This planar loop is off-axis with respect to the shaftaxis “A.” Thus, in either the partially exposed or fully exposedposition, the deformable loop is slanted with respect to the axis “A” ofthe shaft assembly 55. Since the snare 57 is substantially planar inthis fixed, partially exposed position, the loop snare 57 travelslinearly as it is further retracted into a fully hidden, retractedposition.

The second actuator 52, which comprises a lockout trigger or thumb slidein the preferred embodiment, controls movement of the snare 57 from thefixed partially exposed configuration to the fully retracted position,and locks the snare 57 in the fully retracted configuration. When theslide rod 53 is proximally extended to the spring biased rest position,a mating mechanism is provided between the slide rod 53 and the trigger52 such that proximal actuation of the trigger 52 moves the slide rod 53proximally which further retracts the snare 57. In the preferredembodiment, the mating mechanism comprises a notch 66 formed in theslide rod 53 which is configured to mate with an inwardly protruding fin67 of the trigger 52.

When the slide rod 53 is in the spring-biased rest position, the notch66 is aligned with the fin 67 such that proximal movement of the trigger52 engages the slide rod 53 and pulls the slide rod 53 out to its mostextended proximal position which fully retracts the snare 57. Thelockout trigger 52 is then locked to the needle housing 50 by matingfeatures between the two. In the preferred embodiment, a tongue 68 onthe trigger 52 mates with a groove 69 formed in the sidewall of thehousing 50. To unlock the trigger 52, the distal end 71 of the trigger52 can be slightly lifted away from the needle housing 50 to release thetongue 68 from the groove 69. A second spring mechanism 73 biases thetrigger 52 distally and moves the unlocked trigger 52 to its proximalmost position, at which point the trigger 52 is released from the sliderod 53. When the trigger 52 is unlocked from the housing 50 disengagedby the user, the first and second spring mechanisms 64, 72 distally urgethe first and second actuators 53, 52, respectively, thereby returningthe extender to the rest position allowing for partial exposure of thewire snare 57 (as in FIG. 4B).

In the preferred embodiment shown in FIG. 6C, the lockout trigger 52 isdisposed on an outer surface 73 of the cylindrical housing sidewall 74opposite to the exit of the snare and constrained by side tracks 75 anda top slot 76. Other features on the housing outer wall 74 may beemployed to constrain the trigger 52. As the trigger 52 is pusheddistally by the second spring mechanism 72, the trigger 52 rides alongthe ramped tracks 75 and through the top slot 76 formed in the housingsidewall 74 which separate the slide 52 from the rod 53 and facilitatesdisengagement thereof.

Referring back to FIG. 4A, the needle housing 50 may also have a quickconnect mechanism, such as a luer connection 51 somewhere along itslength. The luer connector 51 allows for an inert gas line to beconnected to the needle apparatus 49. As the gas enters the needleapparatus 49, it flows distally through the hollow insufflation lumen,or insufflation channel, 41 of the needle shaft 55 and exits the needleapparatus 49 at the distal tip. This allows for insufflation of theabdominal cavity. FIG. 5A is a detailed view of the needle apparatus 49showing a first preferred embodiment of a blunt obturator assembly 77 ofparticular use when the needle apparatus 49 is used as an insufflationdevice.

In FIG. 6A, the obturator assembly 77 comprises a first preferred bluntobturator tip 78 having a generally flat top 79 at a distal end. Theneedle shaft 55 has a sharp needle tip 82 at a distal end preferablycomprising a needle peak 83 and a pair of blade edges 84 extendingproximally and laterally therefrom, as shown in FIGS. 7A-7D. The needletip 82 facilitates insertion of the needle shaft 55 through the tissuelayers. In order to prevent damage to the underlying organs, the springloaded blunt obturator tip 78 is slidably disposed within the needleshaft 55. The blunt obturator tip 78 is connected to an obturator shaft86 by a dowel pin 87. A window cutout 88 in the obturator shaft 86provides a location for the snare 57 to exit the needle apparatus 49.The blunt obturator tip 78 partially extends up the length of theobturator shaft 86. An exit section 90 adjacent to the window cutout 88has two tracks, or exit slots, 92 to accommodate the passage of thesnare 57. The preferably two distinct tracks 92 prevent the snare 57from being pulled all the way up the needle shaft 55, or becomingtwisted as it is retracted and extended from the shaft 55.

FIG. 6B shows a cross-sectional view of the distal tip of the needleinstrument. One of the needle tracks 92 is shown to guide the wire snare57 distally out the window cutout 88 in the obturator shaft 86. Theneedle tracks 92 also guide the snare 57 proximally into the push rod 93that extends proximally.

In the preferred embodiment, the shaft assembly 55 comprises an innersnare push rod 93 disposed within the obturator shaft 86, which isdisposed with an outer shaft 43 that forms the distal needle tip. Theinner obturator shaft 86 defines the insufflation lumen 41.

Referring back to FIG. 5A, the internal workings of the needle apparatus49 are shown in FIG. 6. The needle shaft 43 is connected to the distalend 58 of the needle housing 50 via a needle hub 94. The obturator shaft86 which is slidably disposed within the needle shaft 55, connects to aobturator hub 95 that is proximal to the needle hub 94. The obturatorhub 95 is slidably disposed within the needle housing 50 and springloaded by a spring 96 that allows the obturator shaft 86 to translate asthe obturator tip 78 is pressed against.

The snare push rod 93 is slidably disposed within the needle housing 50and the obturator shaft 86 and fixed to the slide rod 53. The snare 57is fixed to the proximal end 59 of the slide rod 53 and travels throughthe slide rod 53, through the snare push rod 86, and ultimately outthrough the obturator tip 78 (as shown in FIG. 5). Since the snare 57 isflexible, it requires passage through rigid structures so that it canextend and retract at the needle tip.

At the proximal end of the slide rod 53 is a slide rod pin 65 that mayserve multiple purposes. The pin 65 helps to maintain the rotationalalignment of the slide rod 53 within needle housing. The pin 65 alsoengages the first spring mechanism, or the slide rod spring, 64 when thesnare 57 approaches retraction back into the needle, partially springloading the travel of the slide rod 53 distally back to the restposition.

As discussed above, the trigger 52 is also spring loaded by a secondspring mechanism, or trigger spring, 72, causing the trigger 52 to bebiased in the distal direction. As the trigger 52 is pulled proximally,it engages with the slide rod 53, and pulls it back against the force ofthe slide rod spring 64. The lockout trigger 52 can then be locked tothe needle housing 50, locking out the snare 57 in the fully retractedposition. Both the trigger spring 72 and slide rod spring 64 areconstrained to the needle housing 50 by proximal plugs 98 that may bepinned to the needle housing 50.

FIGS. 7A and 7B provide close-up view of the obturator assembly 77 withthe flattop obturator tip 78. The flattop obturator tip 78 has a flatfront 95 with rounded corners 102.

FIGS. 7C and 7D show a second preferred obturator assembly 110 having aunique ramped obturator tip 112. The ramped tip obturator tip 112comprises an obturator peak 114 with a smaller cross sectional area “C”,allowing for more exposure of the sharpened blade edges 84 of the outerneedle shaft 55. In the preferred embodiment, the ramped surfaces 116are positioned proximally to the blade edges 84 when the obturator peak114 distally traverses the needle peak 83 up to 5 mm. The obturator peak114 defines a surface area preferably less than 0.1 square mm. In thepreferred embodiment, the surface area of the obturator peak 114 is 0.06square mm or less. Moving proximally away from the distal obturator peak91, the cross-sectional area of a tapered section 116 increases in area,until the area at the base 118 of the tapered section 116 is equivalentto the distal end 121 of the obturator tube 123. FIG. 7B shows thedistance “D1” the flattop distal tip 85 needs to be from the needle peak83 to expose the sharp needle edges 84. FIG. 7D shows this a shorteneddistance “D2” with the ramped obturator tip design 110 between theneedle peak 83 and the obturator peak 114. This preferred ramp obturatortip 110 allows the spring loaded obturator mechanism to advance in aquicker manner through the tissue layer and thus provide enhanced safetyby reducing the exposure time of the sharp needle peak 83. The preferredramp obturator 110 may also facilitate the ease of insertion of theneedle through the tissue layers.

Alternative ergonomic handle designs are proposed in FIGS. 8A-8C. InFIG. 8A a simplified alternative handle design is shown, compared to theprimary embodiment disclosed above. A handle 130 is shown with twoextension tabs 134 that can be supported in the hand by two fingers(such as the index and middle finger). The plunger 136 has a surface 138that can be pressed by another finger (such as the thumb) in order toadvance the plunger 136 and deploy the snare. The plunger 136 may bespring loaded with respect to the handle 130, so that the plunger 136 isbiased in the direction that retracts the snare.

In FIG. 8B, an alternative preferred embodiment of a handle 140comprises two finger slots 142 each configured to receive a finger, anda hole 144 formed on the plunger 146 for receiving a thumb. As the thumbslides distally, the plunger 148 also advances distally inside thehandle 140, deploying the snare.

In FIG. 8C, a further preferred embodiment of a handle 150 comprises aninverted design with respect to the embodiment shown in FIG. 8B. Here,two fingers (such as the index and middle fingers) can be placed insidethe finger slots 152 on the plunger 154, while another finger (such asthe thumb) can be placed in the hole 156 of the handle 150. In thisembodiment, the two fingers in the plunger 154 would be advanceddistally to deploy the snare.

The following describes a preferred method of wound closure or suturepassing using the first preferred embodiment of the wound closure systemdescribed above in connection with FIGS. 1-6. The guide plunger 21 istranslated, preferably pressed down, to contract the feet 26, andcausing the guide 10 to take a slender, continuous profile as shown inFIG. 1B. With the plunger pressed down and the guide taking a slenderprofile, the guide 10 is inserted through the tissue, particularlythrough a surgical wound or opening. The plunger 21 is released and theexpanding feet 26 are placed against the peritoneal wall (FIG. 3).

With the guide 10 inserted through the trocar wound and secured to theinner wall, attention is turned to the needle apparatus 49 which alsofunctions as a suture engaging device. The lockout trigger 52 isreleased to partially extend the snare 57 (FIG. 4B). In FIG. 9, asection of suture 160 is placed into wire snare 57. As shown in FIGS. 4Aand 5A, the lockout trigger 52 is actuated and the snare 57 is retractedto capture the section of suture 160 within the distal tip of the needleapparatus 49.

In FIG. 10, the needle apparatus 49 is then placed through one of theguide barrel needle entry slots 27, through the needle tunnels 35 in theplunger 21, out the needle exit slots 28, and through the tissue 36, 37,38 into the abdominal cavity 162. The lockout trigger 52 is released(see FIGS. 4B and 5 b), deploying the snare 57. The needle apparatus 49can then be further advanced into the cavity 162 to release the sectionof suture 160. The lockout trigger 52 is again actuated to retract thesnare 57, and the needle apparatus 49 is removed from the guide 10 andtissue layers 36, 37, 38. The needle apparatus 49 is then inserted intothe opposing needle entry slots 27 of the guide 10 and through thetissue layers 36, 37, 38. The lockout trigger 52 is released topartially deploy the wire snare 57. The slide rod 53 is fully translatedinto the needle housing 50 to fully deploy the snare 57. The needle 49can then be rotated or manipulated to place the snare 57 underneath thefree end of the suture 160.

In FIG. 11, the needle apparatus 49 is then slightly pulled proximallyto encircle the suture 160 inside the snare 57. The slide rod 53 ispulled back proximally to the spring-biased rest position, and thelockout trigger 52 is actuated to capture the suture 160 in the tip ofthe needle apparatus 49. The needle apparatus 49 is then pulled out ofthe body and guide 10. One last time the lockout trigger 52 is releasedto partially extend the snare 57. The suture 160 is then removed fromthe snare 57. The guide is then removed to freely expose the sutureends. A knot is tied between the two free ends of the suture 160 that isused to close the wound site.

FIG. 12 illustrates a preferred method 200 for insufflating a bodycavity and engaging a suture to close a wound using a single device. Themethod 200 comprises the step 210 of insufflating the body cavity with ashaft defining an insufflation channel along an axis between a shaftdistal end and a shaft proximal end. Step 220 comprises securing asuture with a snare disposed adjacent to the shaft distal end. In step230, the shaft with the secured suture is inserted into the body cavityat a desired first location. A guide may be used in step 230 to directthe device to the desired first location. In step 240, the suture isreleased by moving, or actuating, the snare to an exposed position,which may be a partially exposed or fully exposed position. Step 250comprises removing the shaft from the first location.

In step 260, the shaft is inserted into the body cavity at a desiredsecond location spaced apart from the first location. The guide may beused in step 260 to direct the shaft to the second location. Step 270comprises capturing the suture with the snare. In step 270, the snaremay be actuated to a fully exposed position to enlarge the loop andorient the loop substantially perpendicular to the axis of the shaft.Step 280 comprises securing the suture to the shaft by retracting thesnare. Step 290 comprises removing the shaft from the second locationwith the secured suture to complete a stitch loop.

FIG. 13 illustrates a preferred method 300 for closing a surgical woundusing a system comprising preferred embodiments of a guide and a sutureengaging device disclosed above. It will be appreciated that this method300 enables an operator to deploy and capture suture using simply aguide and a suture engaging device without the need for a grasper. Themethod 300 comprises the step 310 of actuating a guide into a slenderconfiguration and inserting the guide through surgical wound. Step 315comprises radially expanding a securing mechanism, which may comprisefeet or living hinges, at a distal end of the guide. Step 320 comprisesretracting the guide such that the securing mechanism engages an innerbody cavity wall surrounding the wound. In step 325, unwanted tissue isseparated away from exits formed in the guide in order to prevent saidtissue from being sutured. Step 325 may be accomplished with axial wingsformed on an outer surface of the guide adjacent to the exit slots.

Step 330 comprises engaging a suture with a snare disposed at a distalend of a suture engaging device having a shaft. In step 330, the snareis actuated to a fully retracted position to capture and lock thesuture. Step 335 comprises inserting the suture engaging device with thesecured suture through a first track of the guide and into the bodycavity at a first position. Step 340 comprises releasing the suture inthe body cavity and retracting the suture engaging device from the firsttrack of the guide. Step 345 comprises inserting the suture engagingdevice through a second track of the guide and into the body cavity at asecond position laterally spaced from the first position. In Step 350,the snare may be deployed up to a fully exposed configuration to capturethe suture. In the fully exposed configuration, the loop issubstantially perpendicular to the axis of the shaft of the sutureengaging device. Step 355 comprises retracting the snare to secure thesuture. Step 360 retracting the suture engaging device with the securedsuture from the guide to complete a stitch loop.

FIG. 14 illustrates a second preferred embodiment of a needle apparatus400 comprising a single actuator 452 as opposed to dual actuatorsincluded in the first preferred needle apparatus discussed above. Inthis second preferred needle apparatus 400, the actuator 452 comprises alockout trigger 452 coupled to a rod assembly 448 that is coupled to asnare 457. Whereas in the first preferred needle apparatus, the lockouttrigger is capable of moving the snare between a retracted position to apartially exposed position, the lockout trigger 452 in the secondpreferred needle apparatus 400 is capable of moving the snare 457between a retracted position, where the trigger 452 is moved to the mostproximal position as shown in FIG. 15, and a fully exposed position,where the trigger is moved to the most distal position as shown in FIG.14.

The lockout trigger 452 rides along a top slot 476 and a pair of sidetracks 475 formed in the housing 450. Since the lockout trigger 452needs to translate a greater distance with respect to the housing,particularly in the proximal direction, the slot 476 and tracks 475 areformed with greater lengths than those of the first preferred needleapparatus 49.

Accordingly, the slide rod 53 of the first preferred needle apparatus 49shown in FIGS. 6A-6C, has been omitted in the second preferred needleapparatus 400 and replaced by the single lockout trigger 452.Furthermore, the second preferred needle apparatus comprises a 402 whichmay be formed integrally with or separately from the housing 450. Thehandle 402 defines a finger slot 403. Except for structural differencesdiscussed above with respect to FIGS. 14-15, all other structures in thesecond preferred needle apparatus 400 as well as the principles ofoperation are substantially similar to those in the first preferredneedle apparatus 49.

Many alterations and modifications may be made by those having ordinaryskill in the art without departing from the spirit and scope of theinvention. Therefore, it must be understood that the illustratedembodiments have been set forth only for the purposes of examples andthat they should not be taken as limiting the invention as defined bythe following claims. For example, notwithstanding the fact that theelements of a claim are set forth below in a certain combination, itmust be expressly understood that the invention includes othercombinations of fewer, more or different ones of the disclosed elements.

The words used in this specification to describe the invention and itsvarious embodiments are to be understood not only in the sense of theircommonly defined meanings, but to include by special definition in thisspecification the generic structure, material or acts of which theyrepresent a single species.

The definitions of the words or elements of the following claims are,therefore, defined in this specification to not only include thecombination of elements which are literally set forth. In this sense itis therefore contemplated that an equivalent substitution of two or moreelements may be made for any one of the elements in the claims below orthat a single element may be substituted for two or more elements in aclaim. Although elements may be described above as acting in certaincombinations and even initially claimed as such, it is to be expresslyunderstood that one or more elements from a claimed combination can insome cases be excised from the combination and that the claimedcombination may be directed to a subcombination or variation of asubcombination.

Insubstantial changes from the claimed subject matter as viewed by aperson with ordinary skill in the art, now known or later devised, areexpressly contemplated as being equivalently within the scope of theclaims. Therefore, obvious substitutions now or later known to one withordinary skill in the art are defined to be within the scope of thedefined elements. The claims are thus to be understood to include whatis specifically illustrated and described above, what is conceptuallyequivalent, what can be obviously substituted and also what incorporatesthe essential idea of the invention.

What is claimed is:
 1. A method of suturing a trocar port site woundcomprising: a) pressing a spring biased plunger of a guide to moveradially expanding feet from a biased extended position to a slenderconfiguration, the feet, in the biased extended position, beingcircumferentially offset to exits of first and second tracks in theguide; b) inserting the guide by linear translation in the slenderconfiguration into a wound site created by a trocar, until the retractedfeet of the guide are through the surgical wound; c) releasing thespring biased plunger of the guide to allow the biased feet to extendradially at opposite locations circumferentially offset to the exits ofthe first and second tracks; d) retracting the guide to position theguide such that the expanded feet are placed against a peritonealtissue; e) grasping a suture with a wound closure device; f) passing thesuture with said wound closure device through the first track in theguide and into the body cavity at a first position; g) releasing thesuture at the first position; h) retracting the wound closure devicefrom the guide, leaving the suture in place; i) inserting the woundclosure device in the second track defined within the guide and into thebody cavity at a second position laterally spaced from the firstposition; j) retrieving the suture from the first position with thewound closure device, and retracting the wound closure device with thesuture from the guide; k) pressing the spring biased plunger of theguide to move the radially expanding feet from the biased extendedposition to the slender configuration; l) removing the guide in theslender configuration from the wound site to freely expose suture ends;and m) tying a knot between the suture ends of the suture to provideclosure of the wound.
 2. The method of claim 1, wherein the insertingsaid wound closure device in said second track comprises exiting thesecond track at the second position located 180 degrees from the firstposition.
 3. The method of claim 1, wherein the first track and thesecond track are each oblique to an axis of the guide.
 4. The method ofclaim 1, further comprising passing the guide through a lumen of anendoscopic port when the expandable member is positioned in the slenderconfiguration.
 5. The method of claim 4, wherein the radially expandingfeet are configured so that when the guide is positioned within anendoscopic port site wound and the radially expanding feet are in thebiased extended position within the body cavity adjacent the endoscopicport site wound, the guide is operable to be pulled proximally to applyan outward force to a wall forming the body cavity on either side of theendoscopic port site wound.
 6. The method of claim 1, wherein a firstend region of each of the radially expanding feet is secured to thedistal end region of a barrel of the guide, a second end region of eachof the radially expanding feet is secured to a base that is axiallymoveable relative to the barrel, and a middle region of each of theradially expanding feet is secured to the first and second end regionsof each of the radially expanding feet.
 7. The method of claim 6,wherein axial movement of the base distally relative to the barrelcauses the radially expanding feet to collapse, and axial movement ofthe base proximally relative to the barrel causes the radially expandingfeet to expand.
 8. The method of claim 1, wherein the first trackterminates at a first distal opening and the second track terminates ata second distal opening, the first and second distal openings beingdefined by respective portions of the guide that are circumferentiallyspaced by about 180 degrees.
 9. The method of claim 1, wherein a firstgap between a first one of the radially expanding feet and a second,adjacent one of the radially expanding feet extends about 30° to about180° around a circumference of the guide.
 10. The method of claim 9,wherein the guide is configured such that the wound closure device, whenextended through the first track and within the first gap, is free fromcontact with any portion of the radially expanding feet or any structuredefined by the radially expanding feet.